EMEA-002722-PIP01-19-M02 - paediatric investigation plan

Etranacogene dezaparvovec

Key facts

• Active Substance:
  Etranacogene dezaparvovec
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0380/2022
• PIP number:
  EMEA-002722-PIP01-19-M02
• Pharmaceutical form(s):
  Concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of Haemophilia B
• Route(s) of administration:
  Intravenous use
• Contact for public enquiries:

  CSL Behring GmbH

  Email: [e-mail]; Tel. [phone];

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  09/09/2022

Decision

P/0380/2022 : EMA decision of 9 September 2022 on the acceptance of a modification of an agreed paediatric investigation plan for etranacogene dezaparvovec (EMEA-002722-PIP01-19-M02)

AdoptedReference Number: EMA/709050/2022